PROSTHESIS SOCKET AND METHOD FOR PRODUCING SAME

Abstract

A prosthesis socket comprising a proximal entry open and a distal end or a distal end region and a fastening system provided there for a prosthesis component, wherein the prosthesis socket has a frame consisting of a fiber-reinforced plastic material with at least one opening, a textile which spans the opening being fixed to the frame.

Claims

1. A prosthesis socket comprising a proximal entry opening and a distal end or a distal end region and an attachment device arranged there for a prosthesis component, the prosthesis socket comprising a frame composed of a fiber-reinforced plastic having at least one free space, wherein a textile bridging the free space is fixed to the frame.

2. The prosthesis socket as claimed in claim 1, wherein the textile completely covers the free space.

3. The prosthesis socket as claimed in claim 1, wherein the textile is in the form of a warp-knitted spacer fabric, weft-knitted spacer fabric or woven spacer fabric.

4. The prosthesis socket as claimed in claim 1, wherein the textile is adhesively bonded and/or thermally bonded to the frame.

5. The prosthesis socket as claimed in claim 1, wherein the frame is formed from prepregs which are applied on an outer side of the textile that faces away from a user.

6. The prosthesis socket as claimed in claim 1, wherein a material having a hardness between that of the frame and that of the textile is arranged as a further ply between the frame and the textile as an intermediate ply, as a surface ply and/or at a prosthesis socket edge as padding.

7. The prosthesis socket as claimed in claim 6, wherein the material of the further ply or of the padding consists of cured elastomer or contains cured elastomer.

8. The prosthesis socket as claimed in claim 1, wherein the frame is joined to the textile and, if applicable, to the further ply via resin from prepregs forming the frame.

9. The prosthesis socket as claimed in claim 8, wherein in the assembled state, resin does not penetrate the textile to the inner side.

10. The prosthesis socket as claimed in claim 1, wherein the textile is in the form of a sleeve or a distally closed liner.

11. A method for producing a prosthesis socket, in which a textile is applied to a stump model, at least one prepreg is applied on the outer side of the textile to form a frame having at least one free space such that the textile at least partially bridges the free space, and the textile and the at least one prepreg are then thermally bonded at an elevated temperature and under application of a vacuum to form a prosthesis socket.

12. The method as claimed in claim 11, wherein the textile used is a warp-knitted spacer fabric, weft-knitted spacer fabric or woven spacer fabric.

13. The method as claimed in claim 11, wherein before being applied to the stump model, the textile is pulled onto a stump and contact areas for the at least one prepreg are marked.

14. The method as claimed in claim 11, wherein the stump model is wrapped up in the textile.

15. The method as claimed in claim 11, wherein the at least one free space is arranged medially or laterally.

16. The method as claimed in claim 11, wherein a closed, distal cap is formed on the prosthesis socket via at least one prepreg.

17. The method as claimed in claim 11, wherein prior to thermal bonding, at least one further ply is placed between the textile and the prepregs and/or padding is placed around a prosthesis socket edge and they are cured together.

18. The method as claimed in claim 17, wherein the further ply and/or the padding contains or consists of at least one uncrosslinked or slightly crosslinked elastomer.

19. A prosthesis socket comprising: a proximal entry opening; a distal end or a distal end region; and an attachment device on the distal end or distal end region for a prosthesis component; wherein the prosthesis socket includes a frame composed of a fiber-reinforced plastic having at least one free space; and further wherein a textile selected from the group consisting of a warp-knitted spacer fabric, a weft-knitted spacer fabric or a woven spacer fabric, is fixed to the frame, completely covering the free space.

20. The prosthesis socket of claim 19, wherein the textile is adhesively bonded and/or thermally bonded to the frame.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Exemplary embodiments of the invention will be more particularly elucidated below with reference to the appended figures, in which:

[0023] FIG. 1-shows a schematic depiction of a prosthesis socket in a side view;

[0024] FIG. 2-shows a rear partial view of the prosthesis socket according to FIG. 1;

[0025] FIG. 3-shows a schematic sectional view through a region of the prosthesis socket; and

[0026] FIG. 4-shows a variant of FIG. 3.

DETAILED DESCRIPTION

[0027] FIG. 1 shows a schematic depiction of a prosthesis socket 10 in a side view. In the exemplary embodiment depicted, the prosthesis socket 10 is in the form of a forearm socket which is to be placed on a forearm stump. To this end, the prosthesis socket 10 is provided with a proximal entry opening 11 in which the forearm stump can be inserted. The prosthesis socket 10 comprises a distal, closed end 12 on which an attachment device 13 for a prosthetic hand is arranged. The attachment device 13 is a schematic depiction of a device for attachment of an adapter to which the prosthetic hand or a prosthetic wrist can be attached. In one embodiment of the prosthesis socket 10, for example in the form of a thigh socket, a prosthetic knee joint is advantageously and usually attached via a pyramid adapter with a corresponding attachment device on the prosthetic knee joint. The pyramid adapter is then usually formed in the region of the distal end of the closed prosthesis socket 10. In the case of an embodiment in the form of a lower leg socket, other attachment devices can also be provided for fixing a prosthetic foot. Since the attachment means for prosthetic hands should take up as little space as possible, a prosthetic wrist is advantageously and usually attached via a lamination ring. However, an attachment device other than a lamination ring can also be provided for fixing the prosthetic hand to the forearm socket. The attachment device 13 depicted can also be oriented differently on the prosthesis socket 10.

[0028] The prosthesis socket 10 is in the form of a frame socket and comprises a frame 20 composed of a fiber-reinforced plastic. The frame 20 is made up of so-called prepregs, which are cut to the desired shape and are placed on a stump model, which is not depicted. The prepregs are resin-impregnated fiber wovens which adhere to one another. Because of the excess resin on the prepregs, the precuts also adhere on whatever is the substrate. In the exemplary embodiment depicted, the frame socket comprises two free spaces 21, 22 in the form of windows. A first window 21 is formed in the rear or posterior region, and the second window or the second free space 22 is formed in the frontal or anterior region. The distal end region 12 is closed and encompasses the blunt end around its entire circumference. Formed in the frame 20 proximally to the closed end 12 is a donning hole 14, through which a donning aid pulled over a liner, for example a sleeve composed of a nonadherent material, can be removed after insertion into the prostheses socket 10. The two free spaces 21, 22 are completely bridged and closed by a textile 30. In the exemplary embodiment depicted, the textile 30 is in the form of a warp-knitted spacer fabric arranged on the inner side of the frame 20. The textile 30 is first attached to the prepregs by means of the excess resin present on the surface of the as yet uncured prepregs and is then, during finishing of the prosthesis socket 10 under application of a negative pressure or vacuum and at an elevated temperature, permanently joined to the fiber composite material that is curing. When producing the prosthesis socket 10, the vacuum is preferably set such that the resin does not penetrate as far as the inner side of the textile 30, but that a soft inner surface of the textile continues to be ensured. The vacuum or the negative pressure makes it possible to adjust the contact force of the prepregs on the textile and to thus alter the degree of penetration by the resin.

[0029] The prosthesis socket 10 is produced, for example, by taking an impression of the stump of the limb and creating a positive model of the stump from said impression. The positive model can be made of plaster, for example. A standard liner or a custom-made liner is pulled onto the plaster model, such that it rests against the surface of the plaster model as smoothly as possible. The prepregs are placed onto the outer surface of the liner and fixed thereto via the bonding power of the excess resin such that the frame 20 is formed. The free spaces 21, 22 or frame windows can be marked on the textile 30 or the liner beforehand. Those regions on which no prepregs are to be placed and which are not to be covered by the fiber composite material can be marked either on the plaster model or directly on the limb stump. To this end, the liner or the textile 30 is pulled onto the limb stump. As a result, it is possible to take into account individual wishes of users and, for example, to identify particularly sensitive regions directly on the subsequent user of the prosthesis socket. One or more plies of an additional material, in the form of an intermediate material 40 in this embodiment, can be arranged between the prepregs or the plies of prepregs and the textile 30. Preferably, the intermediate material 40 is an elastomer or comprises at least one elastomer component. The intermediate material 40 advantageously joins to the material of the prepregs and also to the textile 30. There is also the option of choosing the intermediate material 40 such that the resin of the prepregs penetrates through the intermediate ply, for example because of the presence of perforation or because the material is permeable to the resin. The intermediate material 40 provides padding and is preferably elastic. Furthermore, the intermediate material 40 can be used to accommodate lines and/or electrodes, and so, for example, electrodes arranged inside the prosthesis socket 10 for recording myoelectric signals can be easily integrated.

[0030] Electrode windows 50 can be formed on the frame 20 on the outer side of the prosthesis socket 10. In the exemplary embodiment depicted, only one electrode window 50, which serves to accommodate electrodes or pairs of electrodes, is depicted. For example, control signals from the limb are received via the electrodes, processed in a control unit comprising processor and memory, and used to activate or deactivate drives.

[0031] After completion of the frame contour via the prepregs on the outer side of the textile 30, a vacuum is applied. To this end, the model with the textile 30, with or without the intermediate ply or the intermediate plies, and the as yet uncured fiber composite materials is, for example, wrapped in a plastic cover on the model. The plastic cover is evacuated and the model is heated. The vacuum and the heat are maintained until the prepregs have cured to yield a dimensionally stable frame 20.

[0032] FIG. 2 shows a detailed rear view of the prosthesis socket 10. It can be seen that the textile 30 is arranged and attached on the inner side of the frame 20. A coating 31 can be applied on the inner side of the textile 30 to improve the adherence of the textile 30 to the limb, for example the forearm stump. The coating 31 in the exemplary embodiment depicted consists of silicone and runs in two strips extending from the proximal entry opening 11 up to the distal end region, which is not depicted. The resin from the prepregs forming the dimensionally stable frame 20 has not penetrated as far as the inner surface of the textile 30. The textile 30 is directly joined to the prepregs via the resin from the prepregs. The free space 22 on the back of the prosthesis socket 10 is completely covered by the textile 30, and so the prosthesis socket 11 completely encloses the stump when the prosthesis socket 10 is put on.

[0033] FIG. 3 depicts the connection of a textile 30 to the frame 20 in a schematic sectional view. Moreover, a further material or a further material ply is arranged on the frame 20 as intermediate material 40, this being in the exemplary embodiment depicted, at the left end, on the side of the frame 20 facing away from the textile 30 and, at the right end, between the frame 20 and the textile 30.

[0034] The frame 20 composed of a fiber-reinforced plastic, for example composed of prepregs, has, in its processable state, a tacky surface, which, as described above, is caused by the excess resin. The tack will disappear in a subsequent processing step by curing and crosslinking at elevated temperatures under vacuum. The textile 30 is placed on a surface of the frame 20 and is permanently and directly fixed to the frame 20 by the resin in a transition region 25 upon curing or thermal bonding. In the same way, the intermediate material 40 is fixed to the frame 20 on the side of the frame 20 facing away from the textile 30; here too, the fixing is achieved via the resin on the prepregs and the curing or thermal bonding during further processing. The intermediate material 40 can also be arranged between the textile 30 and the frame 20, as shown at the right end of FIG. 3. The resin then completely penetrates the intermediate material 40 and also joins to a portion of the textile 30, for example to the side of the fabric facing the frame 20. The textile 30 is thus fixed to the frame 20 via the intermediate material 40. The resin preferably does not completely penetrate the textile 30 in order to avoid the presence of cured resin on the inner surface of the prosthesis socket 10.

[0035] Furthermore, in FIG. 3, padding material 41 is arranged at the edge of the prosthesis socket, which padding material was thermally bonded together with the prepregs. The padding material can be the same material as the material of the intermediate ply 40 and can consist of or comprise an elastomer which is cured in its final state.

[0036] FIG. 4 shows a further exemplary embodiment of the invention. FIG. 4 is a variant of the embodiment according to FIG. 3 and likewise shows a schematic sectional view through a proximal region of a prosthesis socket. A textile 30 is positioned on the inner side of the prosthesis socket and is joined to the dimensionally stable frame 20 of the prosthesis socket via a resin layer in the transition region 25. The resin layer penetrates both the textile 30 and the frame 20 in the transition region 25 because the resin is provided from the material of the frame 20 during the production of the prosthesis socket. Excess resin from the starting materials penetrates into the textile 30 at least partially and brings about a permanent and secure connection of the textile 30 to the cured frame 20. Arranged inside the prosthesis socket is a window 50 or a cut-out, into which, for example, an electrode, a sensor, an actuator or the like can be inserted. On the outer side of the frame 20, i.e., on the side facing away from the textile 30, a further material 40 is arranged around the opening or the window 50, which material in its final state consists of a cured elastomer or contains a cured elastomer. This further material ply is applied on the outer side of the frame 40 as a surface ply 40 and forms the uppermost layer, i.e., the layer furthest away from the skin. The surface ply 40 can be applied before or after the introduction of the window 50, and the purpose thereof is that the window 50 can be introduced more easily in order to position electrodes or other devices in the prosthesis socket; furthermore, there are advantages in covering the edge of the hole and in fixing the electrode or the further component within the opening. The surface ply 40 can also be closed or have an opening smaller than the window 50 or surround the edge of the opening.

[0037] At the proximal end or in the region of the prosthesis opening 11, the further material 40 is in the form of a combination of padding and surface ply 40. Both on the inner side of the textile 30, as surface facing the skin, and on the outer side of the frame 20, a layer or a region of the additional material composed of cured elastomer or of material containing cured elastomer is applied in order to protect the edge region of the respective frame 20 and of the textile 30. Furthermore, what is formed on the end face is a lip or padding which protects against the hard edge of the frame 20 during insertion of the limb. Therefore, this edge coating on the outer side, the end face and the inner side means that, firstly, the patient and a more comfortable feel during wearing is achieved and, secondly, the prosthesis socket is protected from mechanical damage.